NEWS HIGHLIGHTS
Published Studies Related to Miacalcin Nasal (Calcitonin Nasal)
Optimizing bioavailability of oral administration of small peptides through pharmacokinetic and pharmacodynamic parameters: the effect of water and timing of meal intake on oral delivery of Salmon Calcitonin. [2008.09.09]
BACKGROUND: To investigate the influence of water intake and dose timing on the pharmacokinetic and pharmacodynamic parameters of an oral formulation of salmon calcitonin (sCT)... CONCLUSION: 0.8 mg sCT with 50 ml of water taken 30 and 60 minutes prior to meal time resulted in optimal pharmacodynamic and pharmacokinetic parameters. The data suggest that this novel oral formulation may have improved absorption and reduction of bone resorption compared to that of the nasal form.
A randomized double-blind placebo-controlled trial to investigate the effects of nasal calcitonin on bone microarchitecture measured by high-resolution peripheral quantitative computerized tomography in postmenopausal women - Study protocol. [2008.04.13]
ABSTRACT: BACKGROUND: Bone microarchitecture is a significant determinant of bone strength.We hypothezise that - compared to placebo - calcitonin impacts on microstructural parameters, with a possible difference between weight bearing and non-weight bearing bones.
Comparison of calcitonin versus calcitonin + resistance exercise as prophylaxis for osteoporosis in heart transplant recipients. [2006.04.27]
BACKGROUND: Rapid bone loss occurs early after heart transplantation. There is no standard therapeutic intervention to prevent osteoporosis in heart transplant recipients (HTR). The purpose of this study was to determine the effectiveness of a regimen combining the antiresorptive properties of nasal calcitonin with the osteogenic stimulus of resistance exercise... CONCLUSIONS: Calcitonin attenuates BMD loss in the total body and femur neck but not in trabecular bone of the lumbar vertebra. Mechanical loading, through progressive resistance exercise, is an osteogenic stimulus in HTR.
The effectiveness of calcitonin on chronic back pain and daily activities in postmenopausal women with osteoporosis. [2006.03]
The aim of this study was to investigate the effect of nasal calcitonin on chronic back pain and disability attributed to osteoporosis. The study design involved three groups of osteoporotic postmenopausal women suffering from chronic back pain... Intranasal calcitonin has no effect on chronic back pain intensity and functional capacity of osteoporotic women regardless of the presence of fractures, degenerative disorders or chronic back pain of non-specific etiology.
Effect of intermittent administration of 200 IU intranasal salmon calcitonin and low doses of 1alpha(OH) vitamin D3 on bone mineral density of the lumbar spine and hip region and biochemical bone markers in women with postmenopausal osteoporosis: a pilot study. [2005.06]
A 1-year prospective, open, randomized, controlled trial was conducted as a pilot study to examine the effect of intermittent administration of 200 IU intranasal salmon calcitonin and 1alpha(OH) vitamin D3 [1alpha(OH)D3] on bone mineral density (BMD) of the lumbar spine and hip as well as on the markers of bone metabolism in women with postmenopausal osteoporosis...
Clinical Trials Related to Miacalcin Nasal (Calcitonin Nasal)
Effects of Water and Food Intake on the Pharmacokinetics and Pharmacodynamics of Oral Salmon Calcitonin in Healthy Postmenopausal Women [Completed]
This is a phase I study to analyze the effect of water and food intake on the bioavailability
and pharmacodynamic of oral salmon calcitonin (SMC021) and salmon calcitonin nasal spray in
post-menopausal women.
Pharmacokinetics/Pharmacodynamics of Oral Salmon Calcitonin in Patients With Osteoarthritis [Completed]
The purpose of this study is to expose patients with OA to calcitonin and to determine plasma
calcitonin levels after administration of 0. 6 mg and 0. 8 mg oral calcitonin and 200 IU nasal
calcitonin. Also the purpose is to assess the effect of different doses of oral calcitonin
(0. 6 mg and 0. 8 mg oral) and 200 IU nasal calcitonin compared to placebo on serum CTX-I and
CTX-II. Finally to assess the tolerance profile of different doses/formulations of oral
calcitonin compared to placebo.
Efficacy and Safety of Salmon Calcitonin Nasal Spray in Improving Muscle Strength and Reducing Pain After Forearm Fracture in Postmenopausal Women [Completed]
Calcitonin has been used for many years for treating osteoporosis in postmenopausal women,
and it has been shown that calcitonin reduces pain after spine and hip fracture in women with
osteoporosis. Therefore, this study assesses the safety and efficacy of salmon calcitonin
nasal spray on muscle strength after a forearm fracture, pain, quality of life and fracture
healing in postmenopausal women.
A Study Comparing Oral Calcitonin to Nasal Spray Calcitonin in Postmenopausal Osteoporotic Women [Recruiting]
The purpose of this study is to compare the effectiveness and tolerability of two
medications, calcitonin nasal spray and a tablet containing calcitonin, in postmenopausal
women with osteoporosis. Osteoporosis is the term used to describe a large group of
diseases, which are characterized by loss of bone density, which makes the bones weaker.
Osteoporosis often occurs in postmenopausal women.
Calcitonin is a hormone found in the human body. Together with other substances, it
regulates the concentration of calcium in the blood and inhibits the natural resorption of
bone. Both medications in this study contain salmon calcitonin (sCT), because this form of
calcitonin is more active than human calcitonin when used as a medicine.
The calcitonin Nasal Spray used in this study is registered and available to doctors in
United States for the treatment of osteoporosis. The medication being tested in this study
is an oral tablet form of salmon calcitonin.
FGF-23 Suppressibility by Calcitonin [Recruiting]
Introduction:
Based on our experience with calcitonin as an FGF-23 suppressive agent in a patient with an
FGF-23 producing tumor we hypothesize that calcitonin may be a physiologically important
regulator of FGF-23 production and secretion in healthy humans.
Aim:
In this study we wish to examine the FGF-23 suppressive effects of calcitonin in healthy
men.
Study Design:
placebo-controlled, cross-over study
Method:
- All twelve subjects are examined on two occasions, once after exposure to placebo 1 ml
NaCl 0. 9% subcutaneously, and once following calcitonin 200 IU/ml subcutaneously
- On both occasions frequent bloodsampling will take place, out an indwelling catheter in
de forearm vein.
- Sampling times: -15, 0, 60, 120, 240, 360, and 480 minutes
- Mealtimes: Calcium and Phosphate intake standardized on both occasions
- All samples are analyzed for FGF-23, using a C-terminal FGF-23 ELISA kit (Immunotopics,
San Clemente, USA) that measures intact and C-terminal fragments of FGF-23, and one
that measures only intact FGF-23
- Samples obtained at T-15, T0, T240 and T480 are stored for later analysis of Ca,
albumin, PO4, PTH, 25-OHD and 1,25-OHD
Endpoint:
A change of 25% in de serum FGF-23 levels in response to a single subcutaneous injection of
calcitonin 200 IU.
|
